Systems and methods for permanent female contraception

ABSTRACT

Methods and devices for treating and occluding a female patient&#39;s fallopian tubes to provide permanent or extended birth control or sterilization.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims benefit of priority to U.S. ProvisionalApplication No. 62/083,838, filed Nov. 24, 2014, the content of which isincorporated by reference herein in its entirety.

FIELD OF THE INVENTION

The present invention relates to medical devices and methods fortreating and occluding a female patient's fallopian tubes to providepermanent birth control or sterilization.

BACKGROUND

Female sterilization typically involves occluding a patient's fallopiantubes, with various procedures using laparoscopic or minimally invasivetrans-cervical approaches. One procedure involves placing flexiblecoil-like devices into the fallopian tubes, which are made of polyesterfibers and metal wires. Tissue in-growth into the implanted devices canblock the fallopian tubes. However, such implants are worrisome due topotential unknown long-term effects.

SUMMARY OF THE INVENTION

The present invention is directed to catheter systems and implantstogether with methods of using such systems and device for occludingreproductive body lumens such as a female's fallopian tubes.

The tubal occlusion procedure described herein is a minimally invasiveprocedure in which a device can be introduced into the patient's uterinecavity trans-cervically. In one aspect of the method of the invention,RF energy is used to ablate a thin layer of tissue in a segment of afallopian tube which can be performed very rapidly, for example in 5 to60 seconds. A second step of the method involves cutting or damagingtissue within the segment to cause trauma, including but not limited toirritation, bleeding, burning, separation, etc. where such trauma leadsto a subsequent adhesion formation across the area of injury. The woundhealing response and adhesion of the walls in the segment canpermanently close the fallopian tube.

The details of one or more embodiments of the invention are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the invention will be apparent from thedescription and drawings, and from the claims.

In one variation, the device includes a system and/or device foroccluding a fallopian tube. Such devices or systems can be coupled to apower supply, vacuum source, etc. to perform the acts described herein.

In one example, such a device comprises a device body having a lumenpassing therethrough, the device body being moveable between a firstprofile and a second profile where in the second profile, where in thesecond profile the device body increases in a planar dimension such thatthan when located inside the fallopian tube the device body flattens thefallopian tube; at least one adhesion producing surface coupled to thedevice body and configured to create trauma to a wall of the fallopiantube to produce a wound healing response; at least one energy deliverysurface on or in the device body and configured to transmit energy froman energy delivery source to the wall of the fallopian tube.

In another variation of the device the second profile comprises anon-linear shape and where the device body is maintained in tension toassume the first profile.

The adhesion producing surface comprises a cutting element. Variationsinclude that the cutting element is advanceable through the lumen andthrough an opening in the device body.

The device can also be coupled to a vacuum source that is fluidlyengaged with a vacuum lumen extending through the device body, where thevacuum lumen is in fluid communication with at least one vacuum portlocated in the device body, where the vacuum lumen is fluidly coupleableto a vacuum source.

The devices described herein can be advanced with a catheter and/or aguidewire, or a combination thereof. When used with a guidewire, theguidewire can extend through the lumen of the device body.

In certain variations, the device includes at least one energy deliveryopening on the device body and where at least one of the energy deliverysurfaces is located on the guidewire such that the energy deliveryopening permits contact of the guidewire with the wall of the fallopiantube.

The adhesion producing surface can be located on an edge of the devicebody when in the second profile, and where rotation of the device bodycauses the adhesion producing surface to create trauma to the wall ofthe fallopian tube.

The device can include at least one hinged element located on the devicebody, where movement of the hinged element away from the device bodycauses the device body to assume the second profile. In certainvariations, the adhesion producing surfaces is on the at least onehinged element.

Variations of the device can include at least one leg member beingextendable from the device body, such that when extended, the devicebody assumes the second profile.

The devices described herein can be configured such that the device bodycan be elastically moveable between the first profile and the secondprofile or plastically deformable between the first profile and thesecond profile.

Variations of the device can include a device body comprising a flexiblepolymer and where the at least one adhesion surface comprises anabrasive surface located on the device body.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a sectional view of a patient's uterus and fallopian tubesshowing a variation of a system for occluding a fallopian tube, whereinthe system includes a catheter carrying an implant. FIG. 1A illustratesan initial step in a method wherein a hysteroscope is introducedtrans-cervically into the uterine cavity and the catheter is advancedtoward the opening of a fallopian tube.

FIG. 1B is an enlarged view of a portion of the uterus and fallopiantube of FIG. 1A illustrating another step in a method of the inventionwherein a guidewire is advanced through the catheter and into thefallopian tube.

FIG. 1C is a view similar to that of FIG. 1B illustrating another stepin the method wherein the catheter and implant are advanced over theguidewire to a targeted site in the fallopian tube.

FIG. 1D is a view similar to that of FIG. 1C illustrating another stepin the method wherein a retaining sleeve carried by the catheter isretracted to expose the implant in the targeted site in the fallopiantube, and FIG. 1C also illustrates a subsequent step of deliveringablative energy to walls of the fallopian, and another step of causingtrauma in the site as further shown in FIG. 2A.

FIG. 1E is a view similar to that of FIG. 1D illustrating another stepin the method wherein the guidewire is withdrawn from the implant andthe resilient implant moves to its non-tensioned configuration toflatten the fallopian tube.

FIG. 2A is an isometric view of an occluding device or implant carriesby the catheter of FIGS. 1A-1D, with the implant body being maintainedin a tensioned linear shape by the guidewire in a passageway of theimplant, with FIG. 2A further illustrating a blade element that can beextended from the implant to cause trauma in the targeted site in thestep of FIG. 1D.

FIG. 2B is another view of the implant of FIG. 2A with the implant bodyin a non-tensioned shape having multiple curves with the guidewirewithdrawn from the implant, and further illustrating the blade elementextended from the implant for causing trauma in the targeted site, forexample, in the step of FIG. 1E.

FIG. 3 is a graphic representation of the fallopian tube with the tubewalls approximated which corresponds to the method step shown in FIG.1E.

FIG. 4A is a sectional view of the fallopian tube of FIG. 3 taken alongline 4A-4A which again corresponds to the method step shown in FIG. 1Ewherein blood accumulates and is trapped in the fallopian tube.

FIG. 4B is a sectional similar to that of FIG. 4A after the passage oftime wherein an adhesion has formed across the lumen of the fallopiantube and further depicting the bio-absorption of the implant body.

FIG. 5 is a perspective view of another variation of occluding device orimplant that includes the functionality of the system and implant ofFIGS. 1A-4B.

FIG. 6A is a perspective view of another variation of occluding deviceor implant in a collapsed or non-extended position.

FIG. 6B is a view of the implant of FIG. 6A in an extended position.

FIG. 7A is a perspective view of another variation of occluding deviceor implant in a collapsed or non-extended position.

FIG. 7B is a view of the implant of FIG. 7A in an extended position.

FIG. 8 is a perspective view of another variation of occluding device orimplant in an actuated position.

FIG. 9A is a perspective view of another variation of occluding deviceor implant in an insertion configuration.

FIG. 9B is a view of the implant of FIG. 9A is a deployed configuration.

FIG. 9C is a view of the implant of FIG. 9B deployed in a fallopian tubeto thereby flatten the tube.

FIG. 10A is a perspective view of another variation of occluding deviceor implant in an insertion configuration.

FIG. 10B is a view of the implant of FIG. 10A is a deployedconfiguration.

FIG. 11A is a perspective view of another variation of implant in aninsertion configuration.

FIG. 11B is a view of the implant of FIG. 11A is a deployedconfiguration.

FIG. 12A is a perspective view of another variation of implant in aninsertion configuration.

FIG. 12B is a view of the implant of FIG. 12A is a deployedconfiguration.

DETAILED DESCRIPTION THE INVENTION

FIG. 1A illustrates a patient's uterus 100 and fallopian tubes 102 oroviducts, which are paired, tubular conduits that extend from the cornua104 of the uterine cavity 105 us toward the ovaries 106. Each fallopianis about 7 cm to 14 cm in length and is defined by three differentsections: the intramural segment 108, the isthmus segment 110 and theampulla 112 (FIGS. 1A-1B). The intramural or interstitial segment 108 ofthe tube continues from the cornua 104 to the isthmus 110 and is about 1cm in length with a 1 mm lumen diameter. The isthmus 108 is a roundcord-like structure that constitutes the medial one-third of thefallopian tube with a 2 mm to 10 mm outer diameter. The lumen of thefallopian tube is lined with a layer of mucous membrane that can havemany folds and papillae. The wall of the fallopian tube includes layersof muscle tissue. The innermost layer has spirally arranged fibers, themiddle layer has circular fibers, and an outer layer has longitudinalmuscle fibers. These muscle fibers provide for peristalsis andantiperistalsis in the fallopian tubes.

FIGS. 1A-1E and 2A-2B illustrate a system 120 that includes an elongatecatheter 122 that carries a releasable occluding device or implant 125(FIG. 2A) adapted to occlude a patient's reproductive lumen such asfallopian tube 102. The catheter 122 can have any suitable length forextending through the working channel 128 of a hysteroscope or endoscope140. In one embodiment shown in FIGS. 1A-1D, the hysteroscope 140 is anarticulating scope that can be articulated in the uterine cavity 105 toview the entry to the fallopian tubes 102 and direct the catheter into afallopian tube 102. In another variation, a straight rigid endoscopecould be used with an appropriate viewing angle of 5° to 30° togetherwith a catheter or catheter sleeve that can be articulated to assist indirecting a catheter working end into a fallopian tube.

In one variation of implant 125 shown in FIGS. 2A-2B, the body 144 ofthe implant comprises a polymeric material with a passageway 145 toallow it advancement over a guidewire 148. In general, the variations ofcatheter working end 150 and implant 125 disclosed herein are adapted toprovide functionality in more than one aspect which thus enables thesystem to effectively occlude fallopian tubes to provide permanentcontraception. In one aspect and function, the system and/or implantprovide a mechanism to deliver energy to the catheter's working end orimplant to ablate tissue in the fallopian tube lumen 152 over anelongated segment. As will be described further below, the ablation ofendothelial tissue over an elongated segment prevents that rapidre-epithelialization of the lumen, and ablation of underlying musclelayers prevents peristalsis which otherwise could move or disruptcoagulum described next. In a second aspect, the system and/or implantprovide means for causing trauma with a targeted segment of a fallopiantube. As will be described further below, bleeding and coagulum at thetargeted site will optimize conditions for fibrosis and adhesionformation in the targeted site for permanent occlusion. In a thirdaspect, as will be described further below, the implant 150 provides a‘dam’ for preventing displacement of the coagulum following bleeding toallow time for the adhesion to fully develop across to coagulum. In afourth aspect, as will be described further below, the implant 150provides a means for approximating fallopian tube walls to lessen oreliminate the adhesion dimension between the walls to accelerate thetime required for adhesion formation. In a fifth aspect, as will bedescribed further below, the implant 150 had a very flexible body 144 toallow its insertion into a tortuous path of a fallopian tube over aflexible guidewire. In a sixth aspect, as will be described furtherbelow, the implant 125 provides a means for resisting movement of theimplant within the fallopian tube 102 which can be the overall shape ofthe implant or barb-like features on the implant or adhesives carried bythe implant for engaging tissue. In a seventh aspect, as will bedescribed further below, the implant 125 can be fabricated at leastpartly of micro-porous polymeric material that allows for tissuein-growth in a scaffold-like implant body. In an eighth aspect, as willbe described further below, the implant 125 can be fabricated at leastpartly of bio-absorbable or bio-degradable material which will lessenits bulk following absorption or degradation.

FIGS. 1A-1E provide an overview of the steps in a method correspondingto the examples disclosed herein, and further functional details of thesystem 120 and implant 125 in each of the steps follow this overview.

In FIG. 1A, an articulating hysteroscope 140 is introducedtrans-cervically and articulated to view in the direction of a fallopiantube 102. The catheter 122 together with a guidewire 148 is thenintroduced through the working channel 128 of the hysteroscope.

FIG. 1B illustrates a subsequent step wherein the physician introducesguidewire 148 into and through the lumen of the fallopian tube 102 to atleast the isthmus segment 110. FIG. 1C then shows another step in whichthe catheter working end 150 is advanced over the guidewire 148 into thefallopian tube 102.

FIG. 1C illustrates one embodiment of implant 125 that is carried by thecatheter working end within a thin-wall sheath 158 that can be retractedto expose the implant 125.

FIG. 1D next shows another step in which the sheath 158 is retracted toexpose and deploy the implant 125 in the intramural and or isthmussegment of the fallopian tube 102. At this step, the system and implantcan be actuated to cause trauma in the targeted segment of the fallopiantube. Also at this step, the implant 125 is still operatively coupled tothe catheter to allow energy delivery from a remote energy source to theimplant as will be described below.

FIG. 1E shows the implant 125 in the fallopian tube after beingde-coupled from the catheter. As will be described below, the implantwhen released from the catheter moves from a first more linear shape toa second non-linear shape that is adapted to flatten the fallopian tubeto thereby approximate walls of the fallopian tube.

Now turning to FIGS. 2A-2B, the implant 125 can be described in moredetail. The implant body 144 can be fabricated of a polymeric materialthat is flexible or the polymer can be more rigid and formed as aslotted tube as is known in the art to provide flexibility. In onevariation, the implant can have a diameter ranging between 1 mm to 3 mmwith a length ranging between 1 cm to 3 cm. In the variation shown inFIGS, 2A-2B, the implant has a passageway 145 to allow it to be advancedover guidewire 148. The guidewire 148 can have a highly flexible tipportion 160 adapted for negotiating through a tortuous path of afallopian tube and a stiffer portion 162 proximal to the highly flexibleportion that can function to straighten the fallopian tube and alsomaintain the implant in a suitable linear shape as in FIG. 2B. In thevariation of FIGS. 2A-2B, the implant 125 can be maintained in atensioned shape by guidewire 148 as shown in FIG. 2A which allows forintroduction into the fallopian as shown in FIGS. 1C and 1D.

FIGS. 2A-2B further illustrate an energy delivery component of thesystem wherein the implant 125 carries opposing polarity bi-polarelectrodes 165A and 165B that are operatively coupled to RF source 170and controller 175. The spaced apart electrodes 165A and 165B are shownin FIGS. 2A-2B in a helical configuration over the length of the implantbut it should be appreciated that such electrodes can have any form orpattern, including circular, linear, dotted, fragmented or concentric inan outer implant surface an inner passageway of the implant. Inoperation, the RF source can be actuated at a suitable power level forabout 5 seconds to 1 minute to ablate tissue in the fallopian tubelumen. In one variation, the mucosal layer is ablated over the length ofthe implant that can be from 1 cm to 3 cm. In this variation, the dutycycle of RF energy delivery can further ablate the underlying circular,longitudinal and spiral muscle layers, which can be a depth of about0.25 mm to 1 mm. The ablation of the muscle fibers over an elongatedsegment then will prevent peristalsis and antiperistalsis and therebyassist in preventing displacement of the implant 125 and blood and/orcoagulum. The ablation step typically would be performed with theimplant in its tensioned shape with the guidewire straightening theimplant. In another variation of the method, the ablation step could beperformed following withdrawal of the guidewire 148 with the implant 125in it non-tensioned configuration. The implant 125 can be a resilientpolymer that is pre-formed in a curved or sinuous shape, wherein theinherent spring-ability of the implant body will urge it toward itsnon-tensioned curved shape. In another variation, the implant'sresiliency to urge its shape toward its curved shape of FIG. 2B also beassisted by a metal spring element embedded in the implant body 144. Theimplant can have any curved shape that can include 1-10 or more curvesor a similar number of angled portions with living hinges. In onevariation the curved or angled portions are configured to provide a flator planar shape when the implant is in its non-tensioned position toflatten the fallopian tube 102 to thereby approximate the walls of thetube.

FIGS. 2A-2B further illustrate a mechanism carried by the catheter andimplant 125 that can be actuated to cause trauma at the site. In onevariation shown in FIG. 2A, it can be seen that a thin flexible blade180, for example of ribbon stainless steel as used in razor blade, canbe moved axially in slot 182 that extends through the catheter andimplant 125 to exit an open slot termination 185 to pierce and cuttissue. The blade 180 can be extended from open termination 185 anextension distance of 1 mm to 5 mm, and usually from 1 mm to 2 mm. Inany event, the depth of penetration of blade 180 into tissue is greaterthan the depth of the ablation to insure trauma that produces a woundhealing response through any ablated layer. In use, with reference tothe method steps of FIGS. 1D and 1E, the catheter and implant 125 can berotated in either direction, and at various degrees of rotation, theblade 180 can be extended and retracted to cut tissue and causebleeding. In use, the blade 180 can be extended following the ablationstep with the implant 125 in either its tensioned configuration (FIGS.1D and 2A) or non-tensioned configuration (FIGS. 1E and 2B).

In another aspect of the method step shown in FIGS. 1D and 1E, anegative pressure source 190 can be actuated contemporaneous with orsubsequent to the cutting step to draw blood from the cut tissue intothe site. As can be understood from FIGS. 2A-2B, the negative pressuresource 190 can be actuated manually or by controller 175 in unison withthe ablative energy, or automatically timed to follow the actuation ofablative energy. The negative pressure or suction can communicate withthe targeted site through the guidewire passageway 148 in the catheterand implant 125, and/or the slot 182 for blade 180 that extends throughthe catheter and implant. In FIGS. 2A-2B, the guidewire passageway 148communicates with the negative pressure source 190 to thereby applysuction forces through a plurality of ports 192 in the implant 125. Inone variation, the suction forces are pulsed to sustain bleeding intothe site. FIGS. 3-4B show that the blade 180 along with the guidewire148 can be withdrawn from the implant 125.

In one variation, the implant 125 is releasably carries by the catheterwithin the retractable sheath 158. Thus, after the sheath is withdrawnas illustrated in FIG. 1D, the implant 125 is free from the cathetershaft but still stabilized in place by the guidewire 148. In othervariation, the implant can be released from the catheter shaft by meansknown in the art, such as (i) a tear-away connection that is broken byretraction of the guidewire 148 or blade 180, (ii) a mechanicalmechanism such as a latching collar; (iii) a meltable polymer connectionthat can be melted by RF or resistive heating; (iv) a frangibleconnector actuated and broken by a heated NiTi element; or (v) anelectrolytic detaching mechanism as known in the art of detachableembolic coils.

Now turning to FIGS. 3-4B, it can be seen how the implant 125 is adaptedto trap blood 200 and coagulum in the site. In FIG. 3, the guide wirehas been withdrawn and the implant 125 is urged toward its non-tensionedshape to flatten the fallopian tube 102 wherein the approximated wallsof the fallopian tube 102 will allow for more rapid adhesion formationbetween the opposing walls as shown in FIG. 4A.

FIG. 3 illustrates the implant 125 in portion of the fallopian tube inits second non-linear shape approximating the walls of the fallopiantube 102. FIGS. 4A and 4B depict a portion of the fallopian tube segmentfollowing approximation of the walls with the pooling of blood andresulting coagulum in the targeted site, followed by adhesion formationin the site and bio-absorption of the body of the implant 125.

FIG. 4A illustrates blood 200 pooling in the flattened segment of thefallopian tube 102. The blood also migrates into the guidewirepassageway 148 through ports 192 and into the blade slot 182 throughopen termination 185.

Of particular interest, it can be understood from FIG. 3 that the curvedshape of implant 125 will help lock it in place in the fallopian tube102 to resist any peristaltic forces that might otherwise dislodge theimplant. Also of particular interest, the curve or curves of the implantbody as shown in FIG. 3 are adapted to function as a dam to prevent theblood and subsequent coagulum from being displaced.

FIG. 4B illustrates the fallopian tube 102 being occluded with adhesion210 which can form rapidly in a few days as the trapped blood/coagulum(FIG. 4A) functions as an optimal scaffold for fibrosis across andbetween the walls of the fallopian tube 102. FIGS. 1G-1H also show theflattening of the fallopian tube 102 which allows a more rapid formationof the adhesion 110 due to the reduced thickness dimension between theapproximated walls of the fallopian tube 102.

FIG. 4B also is a graphic representation of one variation of the deviceand method wherein the implant 125 is bio-absorbable and FIG. 4billustrates that the implant 125 has been resorbed and replaced with theadhesion 110.

FIG. 5 illustrates another variation of implant 225 that can be used toocclude a fallopian tube using, in general, the same methods asdescribed in FIGS. 1A-4B. The body 226 of implant 225 can comprise aslotted polymer tube having interior lumen 228 in which the slots 240can have selected dimensions to allow a rigid polymer tube to beflexible to follow a guidewire 248 within a tortuous path. The slots canbe formed to provide flexibility in 360° as is known in the art. In thisrespect, the polymer sleeve can comprise a bio-absorbable orbio-degradable material that is substantially rigid but made flexible bythe slots 240.

Still referring to FIG. 5, the ablation functionality of the implant canagain be provided by an RF source and spaced apart opposing polarityelectrodes can be printed on the surface of the implant body 226. Inanother variation, the surface of the implant body 226 can haveelectro-less plating of gold or another conductive metal to provide afirst electrode and the guidewire 248 can comprise a second opposingpolarity electrode.

Still referring to FIG. 5, the mechanism to cause trauma associated withthe implant 225 comprises a cutting element or blade 250 that extendsthrough lumen 228 and can be actuated from the handle of the catheterand can be manually operated or motor driven. The blade 250 can be arotatable thin linear member of a ribbon stainless steel as shown inFIG. 5, but additional variations also include a helical sharp edgedelement or an abrasive wire that can be moved rotational, axially or inboth rotational and axial directions. An additional advantage of thevariation of FIG. 5 is that the negative pressure source 190 can suctiontissue into lumen 228 and the tissue can be cut and captured in thelumen 228. The cutting depth is sufficient to cut through the ablatedtissue layer. The implant 225 can be moved slightly both axially androtationally while actuating the blade to resect the entire surfacelayers of the fallopian tube lumen 152. As a result, trauma is causedand further, the approximated walls or the fallopian tube 102 will beraw tissue, instead of ablated layers with cuts therein as shown in theembodiment in FIGS. 1A-4B. It is believed that adhesions will form morequickly with the exposed cut tissue interfacing the coagulum in thetargeted site (cf. FIGS. 3-4B).

Still referring to FIG. 5, the implant 225 can flatten the fallopiantube by providing a pull wire in the side of the sleeve to cause a curvein the implant (not shown). In another variation, a heat shrink polymercan be provided on one side of the implant that can be heated to deformthe implant. Thus, the implant 225 of FIG. 5 can provide all thefunctions as described in the previous embodiment, including:flexibility to follow a tortuous path, an RF electrode arrangement toablate tissue, a cutting mechanism to cause bleeding in a targeted site,means to flatten the fallopian tube and means to trap the coagulum inthe targeted site.

FIGS. 6A-6B illustrate another variation of implant 275 for occluding afallopian tube that can function to perform the methods as describedpreviously. The body 276 of implant 275 again can comprise polymers witha guidewire lumen 278 to accommodate guidewire 280. The implant hasfirst and second (outer and inner) elements 282 and 284 that can beactuated to flatten the fallopian tube lumen. The outer element 282 hasa flexible medial section that carries an abrasive edge 285 for exampleof diamond powder. Thus, the outer element 282 can be rotated to abradeand cut tissue to cause trauma when is a collapsed or partly collapsedposition. Further, the inner and outer elements 282 and 284 can bepatterned with surface electrodes to perform the ablation step. Toactuate the implant to an expanded shape as in FIG. 6A, the innerelement 284 can be pulled proximally to bend the outer element 284 whichcan be locked in place by a ratchet mechanism, heat actuated meltadhesion of the elements or any suitable mechanical locking mechanism.Thus, the implant 275 of FIGS. 6A-6B can again provide the key functionsof previous variations, including: flexibility to follow a tortuouspath, an RF electrode arrangement to ablate tissue, a cutting mechanismto cause trauma in a targeted site, means to flatten the fallopian tubeand means to trap the coagulum in the targeted site.

FIGS. 7A-7B depict another variation of implant 325 for use in occludinga fallopian tube that again can function to perform the methodsdescribed above. The body 326 of implant 325 has first and second, orrespectively, outer and inner polymer sleeve elements 332 and 334 thatcan be actuated to expand leg elements 335 laterally to flatten thefallopian tube lumen. It can be seen that the outer element has aplurality of slots 340 and the inner element 334 has living-hinged legelements 335 that can lay flat in the slots 340 in the insertionconfiguration of FIG. 7A. The inner sleeve 334 can be moved axiallyrelative to outer sleeve 332 over guidewire 342 as shown in FIG. 7B tocause the leg elements 335 to be flexed outwardly. The extended legelements 335 then will trap blood and coagulum in the site, with themechanism to cause bleeding described below.

In order to perform the step to cause trauma in the targeted site in afallopian tube, the outer sleeve element 332 has a surface 345 coveredat least in part with abrasive particles, for example diamond particlesor powder bonded to the surface 345. Thus, the outer element 332 can berotated to abrade and cut tissue to cause bleeding (or trauma asdescribed herein) when the implant 325 is in the non-expanded positionof FIG. 7A. The implant 325 also allows for negative pressure to beapplied to the site through the outer sleeve lumen 350 that accommodatesthe inner sleeve 334. In order to provide the ablation step, the outersurface 345 also can comprise a first polarity electrode with theguidewire 342 comprising the second polarity electrode.

To actuate the implant 325 to an extended or expanded shape of in FIG.7B, the inner element 334 is pulled proximally to outwardly flex the legelements 335 which can be locked in place by a ratchet mechanism, heatactuated melt adhesion of the elements or any suitable mechanicallocking mechanism. Thus, the implant 325 of FIGS. 7A-7B can againprovide the functionality of previous variations, including: flexibilityto follow a tortuous path, an RF electrode arrangement to ablate tissue,an abrasive mechanism to cause trauma in a targeted site, means toflatten the fallopian tube and means to trap the coagulum in thetargeted site.

FIG. 8 illustrates a portion of another variation of implant 425 foroccluding a fallopian tube that functions to perform methods describedpreviously and is similar to the implant 325 of FIGS. 7A-7B. In FIG. 8,the body 426 of implant 425 has outer and inner polymer sleeve elements432 and 434 that are actuated to extend leg elements 435 outwardly. Inthis variation, the leg elements 435 are hollow and needle-like topenetrate tissue and allow bleeding to flow back to site through ports444 and 445. In other respects, the implant 425 is similar to that ofFIGS. 7A-7B with the leg elements 435 being collapsible into a pluralityof slots 455. The inner sleeve 434 is moved axially relative to outersleeve 432 over guidewire 460 and the extended legs 435 then will trapblood and coagulum in the site. The mechanism to cause bleeding isdescribed in the previous embodiment. The outer sleeve element 432 has asurface 465 covered at least in part with abrasive diamond particlesbonded to the surface 465. Thus, the outer element 432 can be rotated toabrade and cut tissue to cause bleeding when the implant 425 is in thenon-expanded position as in FIG. 8. The outer surface 465 can comprise afirst polarity electrode as described previously.

FIGS. 9A-9C illustrate another variation of implant 515 for a fallopiantube that comprises a flexible polymer with multiple flex elements 518that can flex outwardly to flatten a fallopian tube 102. The flexelements 518 can be resilient and flex outward as in FIG. 9B afterretraction of a retaining sheath (cf. FIG. 1D, 1E and 2B).Alternatively, the flex elements 518 can be flexed by the pull of aninner sleeve in guidewire lumen 520 as shown in the embodiment of FIGS.6A-6B. The implant 515 can have an abrasive surface 522 for causingtrauma as described previously as well as surface electrodes asdescribed in earlier embodiments.

FIGS. 10A-10B illustrate another variation of implant 525 for occluding,a fallopian tube that comprises a polymer with hinged elements 528 thatcan flex outwardly to flatten a fallopian tube. This embodiment includesbarbs 540 for penetrating and gripping tissue. It should be appreciatedthat all of the previous variations can include barb features forengaging the walls of the fallopian tube. In one variation, an implantcan have barbs that point in both the proximal and distal directions toassist in resisting dislodgement when subjected to both peristalsis andantiperistalsis. The implant 525 can have an abrasive surface 522 forcausing trauma and surface electrodes as described in earlierembodiments.

FIGS. 11A-11B illustrate another variation of implant 555 for occludinga fallopian tube that has resilient polymer barb elements 558 that flexoutwardly to grip and flatten a fallopian tube. FIGS. 12A-12B depictanother variation of implant 565 that has resilient flex elements 568that flex outwardly and have barbs 570 facing both proximal and distaldirections to engage and flatten a fallopian tube. The variations ofFIGS. 11A, 11B, 12A and 12B can include a retractable sheath asdescribed previously as well as surface electrodes as described above.

In some embodiments above, the polymer implants are of a bio-absorblematerial. Such materials are well known in the art and can be describedas bio-resorbable, absorbable bio-erodible and can be assimilated by thebody at predictable rates. Bio-resorbable or bio-degradable polymersinclude polylactic acid (PLA) polyglycolic acid (PGA), polydioxanone(PDS), polyhydroxybutyrate (PHB), polyhydroxyvalerate (PHV),polycaprolactone, polycyanocrylates, or polyphosphazenes. As usedherein, the term bio-resorbable includes a suitable bio-compatiblematerial, mixture of materials or partial components of materials beingdegraded into other generally non-toxic materials by an agent present inbiological tissue, for example by being biodegradable or being removedby cellular activity, by bulk or surface degradation, or a combinationof one or more of bio-degradable, bio-erodable, or bio-resorbablematerials.

A number of embodiments of the invention have been described.Nevertheless, it will be understood that various modifications may bemade without departing from the spirit and scope of the invention.Combination of the aspect of the variations discussed above as wellcombinations of the variations themselves are within the scope of thisdisclosure.

1. A device for occluding a fallopian tube, the device comprising: adevice body having a lumen passing therethrough, the device body beingmoveable between a first profile and a second profile where in thesecond profile, where in the second profile the device body increases ina planar dimension such that than when located inside the fallopian tubethe device body flattens the fallopian tube; at least one adhesionproducing surface coupled to the device body and configured to createtrauma to a wall of the fallopian tube to produce a wound healingresponse; at least one energy delivery surface on or in the device bodyand configured to transmit energy from an energy delivery source to thewall of the fallopian tube.
 2. The device of claim 1, wherein the secondprofile comprises a non-linear shape and where the device body ismaintained in tension to assume the first profile.
 3. The device ofclaim 1, where the at least one adhesion producing surface comprises acutting element.
 4. The device of claim 3, where the cutting element isadvanceable through the lumen and through an opening in the device body.5. The device of claim 1, further comprising a vacuum lumen extendingthrough the device body, where the vacuum lumen is in fluidcommunication with at least one vacuum port located in the device body,where the vacuum lumen is fluidly coupleable to a vacuum source.
 6. Thedevice of claim 1, further comprising at least one guidewire extendingthrough the lumen.
 7. The device of claim 6, further comprising at leastone energy delivery opening on the device body and where at least one ofthe energy delivery surfaces is located on the guidewire such that theenergy delivery opening permits contact of the guidewire with the wallof the fallopian tube.
 8. The device of claim 1, where the at least oneadhesion producing surface is located on an edge of the device body whenin the second profile, and where rotation of the device body causes theadhesion producing surface to create trauma to the wall of the fallopiantube.
 9. The device of claim 1, further comprising at least one hingedelement located on the device body, where movement of the hinged elementaway from the device body causes the device body to assume the secondprofile.
 10. The device of claim 9, where at least one of the adhesionproducing surfaces is on the at least one hinged element.
 11. The deviceof claim 1, further comprising at least one leg member being extendablefrom the device body, such that when extended, the device body assumesthe second profile.
 12. The device of claim 1, where the device body iselastically moveable between the first profile and the second profile.13. The device of claim 1, where the device body is plasticallydeformable between the first profile and the second profile.
 14. Thedevice of claim 1, where the device body comprises a flexible polymerand where the at least one adhesion surface comprises an abrasivesurface located on the device body.
 15. The device of claim 1, where theat least one adhesion surface comprises a plurality of barbs.
 16. Thedevice of claim 15, where at least one of the plurality of barbs islocated on a portion of the device body that flexes to assume the secondprofile.
 17. The device of claim 15, where the plurality of barbsinclude pairs of opposingly facing barbs.
 18. The device of claim 1,further comprising a catheter, where the device body is detachable fromthe catheter.
 19. The device of claim 1, where the at least one adhesionproducing surface is exposed in the second profile and when in the firstprofile the at least one adhesion producing surface is prevented fromengaging the wall of the fallopian tube.
 20. A method for occluding afallopian tube using a system including a delivery catheter and implant,comprising: advancing the delivery catheter to thereby position theimplant in a site in the fallopian tube; activating an energy source todelivery energy through the system to ablate fallopian tube tissue atthe site; and actuating the system to cause bleedinga wound healingresponse at the site that produces an adhesion of walls of the fallopiantube.
 21. The method of claim 20 further comprising approximatingopposing walls of the fallopian tube with the implant to assist increating the adhesion.
 22. The method of claim 20 further comprisingwithdrawing the catheter from site and leaving the implant in the site.23. The method of claim 20 wherein advancing the delivery catheterincludes advancing the catheter over a guidewire.
 24. The method ofclaim 20 wherein advancing the delivery catheter includes advancing thecatheter and implant over a guidewire.
 25. The method of claim 20wherein the site is an intramural or isthmus region of the fallopiantube.
 26. The method of claim 2 wherein the implant changes shape toflatten the fallopian tube to thereby approximate opposing fallopiantube walls.
 27. The method of claim 2 wherein the implant deforms shapeto flatten the fallopian tube to thereby approximate opposing fallopiantube walls. 28.-37. (canceled)
 38. A method for occluding a fallopiantube, comprising: providing a system including a catheter and animplant; advancing the delivery catheter trans-cervically to therebyposition the implant in a targeted site in the fallopian tube; andactuating a system mechanism to produce a wound healingresponsebleedingat the site, and causing the implant to approximate wallportions of the fallopian tube to facilitate adhesion formation in thesite to thereby occlude the fallopian tube. 39.-52. (canceled)